A Comparison Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Congenital Factor VII Deficiency

被引：10

作者：

Faranoush, M. ^{[1
]}

Abolghasemi, Hassan ^{[2
]}

Toogeh, Gh. ^{[3
]}

Karimi, M. ^{[4
]}

Eshghi, P. ^{[2
]}

Managhchi, M. ^{[3
]}

Hoorfar, H. ^{[5
]}

Dehdezi, B. Keikhaei ^{[6
]}

Mehrvar, A. ^{[7
]}

Khoeiny, B. ^{[8
]}

Kamyar, K. ^{[8
]}

Heshmat, R. ^{[3
]}

Baghaeipour, M. R. ^{[9
]}

Mirbehbahani, N. B. ^{[10
]}

Fayazfar, R. ^{[11
]}

Ahmadinejad, M. ^{[12
]}

Naderi, M. ^{[13
]}

机构：

[1] Iran Univ Med Sci, High Inst Res, Rasool Akram Hosp, Iranian Blood Transfus Org, Tehran, Iran

[2] Shahid Beheshti Univ Med Sci, Tehran, Iran

[3] Univ Tehran Med Sci, Thrombosis & Hemostasis Res Ctr, Tehran, Iran

[4] Shiraz Univ Med Sci, Shiraz, Iran

[5] Isfahan Univ Med Sci, Esfahan, Iran

[6] Ahwaz Univ Med Sci, Ahvaz, Iran

[7] MAHAK Childrens Hosp, Tehran, Iran

[8] Aryogen Zist Darou Co, Karaj, Iran

[9] Iranian Comprehens Hemophilia Care Ctr, Tehran, Iran

[10] Golestan Univ Med Sci, Gorgan, Iran

[11] Kerman Univ Med Sci, Kerman, Iran

[12] IBTO, Tehran, Iran

[13] Zahedan Univ Med Sci, Ahvaz, Iran

来源：

CLINICAL AND APPLIED THROMBOSIS-HEMOSTASIS | 2015年 / 21卷 / 08期

关键词：

hereditary; factor VII; deficiency; AryoSeven; NovoSeven; Iran; PROPHYLAXIS; HEMOPHILIA; INHIBITORS; THROMBOSIS; EFFICACY; RFVIIA; EXPERIENCE; THERAPY;

D O I：

10.1177/1076029614522545

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

In order to establish the efficacy and biosimilar nature of AryoSeven to NovoSeven in the treatment of congenital factor VII (FVII) deficiency, patients received either agent at 30 g/kg, intravenously per week for 4 weeks, in a randomized fashion. The primary aim was to compare FVII:coagulation activity (FVII:C), 20 minutes after recombinant activated FVII (rFVIIa) injection, in the 2 groups. A secondary measure was self-reported bleeding. The median interquartile baseline range of the plasma level of activated FVII (FVIIa) activity in the 2 groups was 1.6 (1.1-14.0) IU/dL and 5.0 (1.1-25.5) IU/dL. All patients achieved levels of FVIIa (FVII:C) >30 IU/dL, 20 minutes after the injection of rFVIIa. Bleeding was similar between the 2 groups, with a comparable decrease in severity and frequency compared to the last month prior to treatment. AryoSeven is similar to NovoSeven in increasing postinjection FVIIa activity as well as in clinical safety and efficacy.

引用

页码：724 / 728

页数：5

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